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The Integrated Child Development Services of India provides Supplementary Nutrition Program (SNP) to preschoolers. Using this platform, the current study examined the impact of diversifying a cereal/pulse-based SNP-meal with guava on iron status and cognitive development among 24-48 months old children. A three-arm, nonblinded, cluster-randomized controlled trial (CTRI/2014/09/004983) included 399 beneficiaries from 28 preschools in 16 villages in Telangana state, India. The villages were randomly assigned to receive 25 g of guava (guava group (GG)), banana (banana group (BG)), or cucumber (cucumber group (CG)) along with a SNP meal for 140 days. Nutrient biomarkers (iron status, plasma vitamin C, vitamin B12 , and folate), cognitive development, anthropometric indicators (WAZ, HAZ, and WHZ), and morbidity were assessed at baseline and endline. A linear mixed model and a generalized estimating equation were applied to compare changes in outcomes across the groups. All outcome variables were comparable across groups at baseline. The iron to vitamin C molar ratio improved in the GG from 1:1.4 to 1:12 but remained unaltered in control groups. Higher hemoglobin (P = 0.002), serum ferritin (SF; P < 0.001), vitamin C (P = 0.047), and lower soluble transferrin receptor (sTfR; P < 0.001) causing decreased prevalence of iron deficiency (ID) (P = 0.003) were observed in the GG compared with BG and CG. Prevalence of acute respiratory infection (ARI) was lower in the GG (P = 0.035) versus controls. No impact was observed on cognitive development or growth. Thus, diversifying a cereal/pulse-based meal with guava increased meal vitamin C content, thereby reducing ID and ARI-related morbidity. This approach represents a valid and scalable strategy to address ID among young children.

Iron deficiency anemia (IDA) is a significant public health issue in India affecting nearly all vulnerable segments of the population. Causes of IDA include low consumption of iron-rich foods combined with poor iron bioavailability of nonheme iron sources. To date, interventions aimed at correcting IDA focus on increasing iron intake through iron supplementation or fortification strategies. In contrast, dietary diversification is a long-term sustainable approach to improve bioavailable iron intake. In this context, the inclusion of vitamin C-rich fruits in the regular diet has proven to improve iron absorption, but the effect on iron status is inconclusive. Considering the ongoing national program for preschoolers in India, we designed a cluster randomized controlled trial (RCT) to test the hypothesis that inclusion of vitamin C-rich fruit in a regular meal would improve iron absorption and lead to better child iron and micronutrient status, cognitive development, gut health, and growth while reducing morbidity. This paper illustrates a context-specific framework and activities to design and functionalize an open-label, three-arm cluster RCT to test a specific hypothesis. The results of this designed trial should generate evidence to inform policy on the effect of a food-based intervention on iron status.